BIOVIA
CISPro allows you to track and report on your inventory while meeting safety and regulatory
requirements. CISPro stores information about materials, their quantities, production dates, and
locations.
Study Design and Tracking defines the investigation of materials.
Because Study Design and Tracking connects to CISPro, you can select lots when creating a study. This reports information about the
available quantity of each lot and its packaging. During the definition of tasks, this
information allows you to ensure that there is sufficient material of each lot for the
requested tasks.
When you activate a study, this defines a sample in Foundation Hub for each test and updates the remaining amount of each corresponding CISPro lot.
- Products
- A product is an active pharmaceutical ingredient (API) in a formulation. In Study Design and Tracking, you can test pure products or formulated materials combining the product
with other components, such as excipients.
- Materials
- A material is a well-defined and characterized formulation comprising one or
more ingredients, including the API. In Study Design and Tracking, you select CISPro materials to investigate.
- Batches
- A batch is an instance of a material, either planned or manufactured by a
defined process. The terms "batch" and "lot" are often used as synonyms in
stability testing. In Study Design and Tracking, the term "batch" is generic and "lot" refers specifically to a manufactured
or received quantity of material in a given location.
- Manufacture Lots
- Manufacture of a material generates a physical substance, identified as a
manufacture lot with a unique ID.
- Receipt Lots
- Receipt of a manufactured lot (or some portion) assigns the material in the receiving
location a unique ID. Sometimes the Manufacture Lot ID and the Receipt Lot ID
are the same. In Study Design and Tracking, you select or request CISPro receipt lots to investigate. When you request manufacture of a new lot of an
existing or new material, Study Design and Tracking assigns a placeholder Manufacture Lot ID. When you record receipt of the
manufactured material in CISPro this updates the Manufacture Lot ID and CISPro Receipt Lot ID.
- Containers
- A container is the physical object that holds the receipt lot or part of it. This either
contains many Eaches (such as syringes) or the lot substance itself.